The FDA will consider whether to expand the HPV vaccine for women between 27 and 45 years old, according to a statement from the drugmaker. You may recall that Gardasil is currently approved for use in girls and women between 9 and 26 years old to block four types of humanpapilloma virus, which can lead [...]

The drugmaker is having a rough time. The earnings report released today shows a steeper decline in fourth-quarter profit than analysts estimated and, to top it off, Glaxo ceo JP Garnier says earnings will drop this year, mostly due to docs abandoning the Avandia diabetes pill over safety concerns.
In response, Glaxo shares plunged as [...]

Sanofi-Pasteur is criticizing Glaxo’s new Cervarix in an attempt to bolster its lead in the burgeoning market for HPV vaccines, The Financial Times writes. The vaccine maker, which sells Merck’s Gardasil in Europe, has been wooing investors this week with presentations claiming greater proven health benefits from Gardasil in preventing human papilloma virus infections, which [...]

Welcome to the working week. We hope you enjoyed yourselves and feel refreshed, especially those of you who spent last night on the edge of your seats watching the Super Bowl. Not a bad contest, eh? Now, though, it is time to catch up with events. So grab a cup of something hot or a [...]

And so we all return from the weekend. Hope yours was enjoyable. Ours was splendid. We managed to mow the lawn yesterday, a rare event that met with the approval of the neighbors (not that we care all that much). And we took the shortest of the short people on a hayride to pick a [...]

This is good news for Merck. Tim Anderson of Prudential Equity wrote an investor note this afternoon in which he says the drugmaker has received a “standard” 10-month review for Cervarix, its HPV vaccine. However, he doesn’t seem surprised.
“This is, essentially, in line with how Glaxo has been guiding recently, but there was the possibility [...]

It may only be a matter of a few months. That’s because Glaxo may launch Cervarix this year if it gets accelerated review by the FDA. The agency could decide this month to grant Glaxo’s vaccine a faster priority review, which could potentially prompt approval and sale by the end of this year, saysof the [...]

Here they are:
Acomplia, the Sanofi-Aventis fat pill;
Cervarix, the Glaxo HPV vaccine;
Galvus, the Novartis diabetes pill;
Gardasil, the Merck HPV vaccine;
Januvia/Janumet, the Merck diabetes treatment;
Nexavar, the Bayer cancer drug;
Prasugrel, the Lilly anti-platelet agent;
Pristiq, another Wyeth antidepressant;
Sutent, a Pfizer cancer drug;
Tykerb, a Glaxo cancer med.
This is according to Standard & Poor’s drug-industry analyst Arthur Wong, who writes:
We believe [...]

Nothing like a game of one-upsmanship. With questions still bubbling over the effectiveness of Merck’s Gardasil in preventing precancerous lesions, Glaxo this afternoon boasts that new data shows its forthcoming Cervarix vaccine is 100 percent effective.
This refers only to HPV types 16 and 18, which are responsible for most cervical cancer cases. At the American [...]

To develop its Cervarix HPV vaccine as fast as possible, GlaxoSmithKline turned its organization inside out by using the so-called ‘One Roof’ method. Simply put, this involved hand-picking a few dozen employees from R&D, marketing, regulatory and manufacturing, who were assigned to work on nothing but the vaccine for several months.
The urgency was due to [...]